Development of an automated HIV self-testing assay

自动化 HIV 自检检测的开发

• 批准号: 10539345
• 负责人: Waseem Asghar
• 金额: $ 44.34万
• 依托单位: FLORIDA ATLANTIC UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-01-01 至 2024-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10539345
• 关键词: 2019-nCoV; Acquired Immunodeficiency Syndrome; Acute; Address; Antibody Response; Automation; Biological Assay; Biological Markers; Blood specimen; Cessation of life; Communicable Diseases; Contracts; Country; Detection; Development; Devices; Diagnostic; Disease Management; Dryness; Fingers; Flavivirus; Goals; HIV; HIV Infections; HIV Seropositivity; HIV-1; Heating; Hepatitis; Human immunodeficiency virus test; Image; Individual; Infection; Intervention; Magnetism; Malaria; Mediating; Methods; Microfluidic Microchips; Microfluidics; Monitor; Patients; Persons; Phase; Prevalence; Protocols documentation; RNA; Reaction; Reagent; Refrigeration; Reverse Transcriptase Polymerase Chain Reaction; Sampling; Sensitivity and Specificity; Specificity; Speed; System; Technology; Testing; Time; Treatment Failure; Treatment outcome; Tuberculosis; Validation; Viral; Viral Genome; Virus; Whole Blood; acute infection; antiretroviral therapy; commercialization; design; fabrication; glucose monitor; improved; isothermal amplification; microchip; microelectronics; novel; rapid detection; rapid diagnosis; self testing; statistics; viral rebound; virus culture

Project Summary Although antiretroviral therapy (ART) is effective in saving AIDS patients' lives, the implementation of ART worldwide has been drastically hampered by the lack of treatment monitoring diagnostics and disease management. According to the recent statistics by USAIDS, the coverage of ART is still only 59%, despite ART being affordable or freely available in most countries. In addition, worldwide, about 1 in 4 of the people that contracted the virus are unaware of their HIV status. One of the fundamental challenges to reduce HIV burden and its prevalence is the absence of HIV self-testing assays which are sensitive enough to detect new HIV infections during the first two-weeks (acute phase) post-infection and viral rebound in virally supressed patients receiving ART. Current self-testing technologies only detect the host antibody response to HIV infection, which usually arises 3-4 weeks after the initial infection and it is not an indicator of therapy failure and viral rebound. No self-testing technologies have yet been commercialized that are able to detect HIV during the early stages of acute infection or viral rebound in suppressed patients on ART. To increase access to HIV testing and to improve treatment outcomes, there is an urgent need to develop reliable and affordable HIV self-testing technologies. To address these challenges, we propose to develop a disposable self-testing HIV-1 chip that can (i) selectively detect HIV from whole blood samples, (ii) be highly sensitive to detect HIV during the acute infection, treatment and viral rebound (<1000 copies/ml), (iii) be rapid (within 40 minutes), (iv) be highly stable (refrigeration-free), and (v) be fully automated (true sample-in-answer- out).

项目摘要 虽然抗逆转录病毒疗法(ART)在挽救艾滋病患者生命方面是有效的，但ART的实施 全世界因缺乏治疗、监测、诊断和疾病而严重受阻 管理层。根据美国国际开发署最近的统计数据，抗逆转录病毒治疗的覆盖率仍然只有59%，尽管 艺术品在大多数国家都是负担得起或免费提供的。此外，在世界范围内，大约四分之一的人 感染病毒的人并不知道自己的艾滋病毒状况。减少艾滋病毒的根本挑战之一 负担及其流行是缺乏足够灵敏的艾滋病毒自我检测检测 感染后头两周(急性期)新的艾滋病毒感染和病毒在病毒中反弹 接受抗逆转录病毒治疗的压抑患者。目前的自我检测技术仅检测宿主抗体反应 对于艾滋病毒感染，通常在首次感染后3-4周出现，不是治疗的指标 失败和病毒反弹。目前还没有商业化的自我检测技术能够检测到 艾滋病病毒急性感染早期或病毒反弹抑制患者接受抗逆转录病毒治疗。增加 为了获得艾滋病毒检测和改善治疗结果，迫切需要制定可靠和 负担得起的艾滋病毒自我检测技术。为了应对这些挑战，我们建议开发一种一次性 自我检测HIV-1芯片，可以(I)选择性地从全血样本中检测HIV，(Ii)高度敏感 在急性感染、治疗和病毒反弹期间检测艾滋病毒(&lt；1000拷贝/毫升)，(Iii)快速(在 40分钟)，(Iv)高度稳定(无需冷藏)，以及(V)完全自动化(真正的答卷抽样- 出局)。